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OncoMatch/Clinical Trials/NCT05155189

A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma

Is NCT05155189 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including C-CAR031 and Lenvatinib for hepatocellular carcinoma.

Phase 1RecruitingZhejiang UniversityNCT05155189Data as of May 2026

Treatment: C-CAR031 · Lenvatinib · Regorafenib (BAY 73-4506) · DurvalumabA study that aimed to assess the safety and anti-tumor activity of CCAR031 injection in unresectable HCC patients.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: GPC3 possibly expressed

GPC3 is possibly expressed in tumor tissues

Disease stage

Required: Stage BCLC B, BCLC C (Barcelona Clinic Liver Cancer)

Barcelona Clinic Liver Cancer Stage B or C (BCLC B/C)

Performance status

WHO/ECOG 0–1

Prior therapy

Min 1 prior line

Must have received: systemic therapy (Sorafenib, Lenvatinib, Donafenib, Apatinib, Atezolizumab, Pembrolizumab, Camrelizumab, Sintilimab, Nivolumab, Toripalimab, Tislelizumab, Oxaliplatin, 5-Fu) — advanced HCC

Patients with relapsed / progressive disease after at least one prior standard systemic therapy for HCC, or ineligible to accept/unable to tolerate the systemic therapies. Standard systemic therapies may include targeted drugs (such as Sorafenib, Lenvatinib, Donafenib, Apatinib), immune checkpoint inhibitors (such as Atezolizumab, Pembrolizumab, Camrelizumab, Sintilimab, Nivolumab, Toripalimab, Tislelizumab) or chemotherapeutic drugs (such as Oxaliplatin and 5-Fu).

Cannot have received: cell therapy

History of prior cell therapy

Cannot have received: Lenvatinib (Lenvatinib)

Exception: C-CAR031 plus Lenvatinib group only

Subjects in the C-CAR031 plus Lenvatinib group must ... have not received prior Lenvatinib therapy

Cannot have received: Regorafenib (Regorafenib)

Exception: C-CAR031 combination with Regorafenib group only

Subjects in the C-CAR031 combination with Regorafenib group must ... have not received prior Regorafenib therapy

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Lymphocyte count ≥ 0.4 × 10^9/L; Platelet count ≥ 60 × 10^9/L; Hemoglobin ≥ 80 g/L

Kidney function

Serum creatinine ≤ 1.5 × ULN

Liver function

Child-Pugh score ≤ 6; Total bilirubin (TBIL) ≤ 2 × ULN; AST and ALT ≤ 5 × ULN; Prothrombin time (PT): prolonged PT ≤ 4 s

Cardiac function

Left ventricular ejection fraction (LVEF) by echocardiography ≥ 45%

Child-Pugh score ≤ 6; ... LVEF by echocardiography ≥ 45%; ... see full laboratory test requirements

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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